Heart Failure, Hypertension
Conditions
Keywords
Hypertension, Heart Failure, Fluids
Brief summary
This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.
Detailed description
The study had the following objectives: 1. Verify that the CoVa Monitoring System does not interfere with implanted devices. 2. Verify that implanted devices do not interfere with the functions of the CoVa Monitoring System. 3. Verify that the CoVa Monitoring System fits on a wide variety of body types.
Interventions
None listed
Sponsors
Baxter Healthcare Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening. * Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device. * Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study. * Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.
Exclusion criteria
* Subject is participating in another clinical study that may affect the results of either study. * Subject is unable or not willing to wear electrode patches as required. * Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches. * Subject is considered by the PI to be medically unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients with Interference between implanted devices and CoVa Monitoring System | One time for up to 15 minutes during a clinic visit for device interrogation |
Countries
United States
Outcome results
None listed